MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/120-30
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2019, evar was performed for the patient with a right iia aneurysm.The right iia was occluded by a plug and coil first, and then a non- endologix (gore/ excluder leg) stent was deployed on the right leg.Its final position was slightly distal than the intended.Then from the left access, the afx2 bifurcated stent graft was implanted.This procedure is outside the indications of use (off- label).Balloon touch up was performed.An angiogram was preformed.A type 3a endoleak was suspected.More balloon touch up was performed.Another non - endolgix (gore/ excluder leg ) stent was added in the right leg.Balloon touch-up was then performed again and the balloon ruptured so it was exchanged to a stiffer coda balloon.An endoleak was still observed and the lumbar artery was also observed.A type 1a endoleak was identified.Two (2) non - endolgix (gore/ excluder cuff) were implanted to the proximal end of the afx2 bifurcated stent graft.Balloon touch up was performed again.A type 3a or 3b endoleak (unknown origin) was suspected.Two (2) more non - endolgix (gore/ excluder legs) stents were implanted alongside in the afx2 bifurcated stent graft.An endoleak was still observed at the end of the procedure.A computed tomography (ct) scan was performed 3 days post op ((b)(6) 2019), no endoleaks were observed and the patient was discharged.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of an intraoperative type ia endoleak resolved with a non-endologix stent and an intraoperative type 3b endoleak treated with bilateral non-endologix stent.The intraoperative type ia endoleak is most likely user related due to the concomitant use with products outside the ifu (off- label) prior and after the endologix devices were implanted.The intraoperative type 3b endoleak is most likely user related due to the intraoperative extra manipulations with the afx2 graft and off-label use of product outside the ifu.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8494165
• Report Number: 2031527-2019-00175
• Device Sequence Number: 13847142
• Product Code: MIH
• UDI-Device Identifier: 00818009014566
• UDI-Public: (01)00818009014566(17)190808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: BEA28-70/120-30
• Device Lot Number: 1967154-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON -ENDOLOIX, GORE/ EXCLUDER CUFF (PLA280300J); NON -ENDOLOIX, GORE/ EXCLUDER CUFF (PLA280300J); NON -ENDOLOIX, GORE/ EXCLUDER LEG (PLC141000J); NON -ENDOLOIX, GORE/ EXCLUDER LEG (PLC161407J); NON -ENDOLOIX, GORE/ EXCLUDER LEGS (PLC181000J); NON -ENDOLOIX, GORE/ EXCLUDER LEGS (PLC181000J)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR